Urinary Tract InfectionNCT02216253
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.
A study testing L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in people with Urinary Tract Infection and Pelvic Organ Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infection, Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
- patients aged ≥ 18 years
Who cannot join
- acute urinary tract infection at the moment of inclusion in the study
- antibiotic treatment prescribed for any other cause than urinary tract infection
- pregnancy
- known allergy to one of the elements of the active compound
- surgery for mesh excision
- surgery for urethral diverticulum
Show all 9Show fewer
- surgery for fistula repair
- surgery for sacral neuromodulation
- any condition precluding the acquisition of written consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Milan, Lombardy, 20100
About this study
Official title: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.
This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.
- Being tested
- L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract, Placebo
- Keywords
- Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo
- Medical subject headings
- Urinary Tract Infections, Pelvic Organ Prolapse, Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf ExtractDrug
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery
PlaceboOther
Placebo tablet twice a day 7 days before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract | Active comparator | The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery Receives: Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract |
| Placebo | Placebo comparator | Placebo tablet twice a day 7 days before and after surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment for urinary tract infection after surgery.
To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.
Measured: 3 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umberto Leone Roberti Maggiore, IRCCS San Raffaele
- Investigators
- Umberto Leone Roberti Maggiore, MD, Principal investigator, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele UniversityStefano Salvatore, MD, Study director, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216253
- Sponsor's protocol ID
- UTI 2014
- Status last verified
- Aug 2015
- First submitted
- 9 Aug 2014
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02216253
- Acronym / sponsor ID
- UTI 2014
- Keywords
- Urinary tract infection, Pelvic organ prolapse, Urinary incontinence, Stress urinary incontinence, Mixed Urinary incontinence, L-methionine, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract | Active comparator | Drug: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf ExtractThe combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet twice a day 7 days before and after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
- patients aged ≥ 18 years
Key exclusion criteria (9 listed)
- acute urinary tract infection at the moment of inclusion in the study
- antibiotic treatment prescribed for any other cause than urinary tract infection
- pregnancy
- known allergy to one of the elements of the active compound
- surgery for mesh excision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-methionine, Hibiscus Sabdariffa and Boswellia Leaf ExtractL-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery | Drug | L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract |
| PlaceboPlacebo tablet twice a day 7 days before and after surgery | Other | Placebo |
Primary outcome
Treatment for urinary tract infection after surgery.
Time frame: 3 weeks after surgery.
To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Leone Roberti Maggiore, MD principal investigator
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
Stefano Salvatore, MD study director
IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in people with Urinary Tract Infection and Pelvic Organ Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment for urinary tract infection after surgery. (time frame: 3 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.